NCT01947244

Doula Home Visiting Randomized Trial

Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 14 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized controlled trial is to examine whether evidence-based home visiting programs enhanced by doula services have effects on positive parenting practices, breastfeeding, and child and maternal health outcomes.

Detailed description

The goal of this study is to evaluate the impact of doula enhanced evidence-based home visiting programs for young mothers in Illinois. Mothers in the intervention group receive home visits from doulas during pregnancy and in the first few weeks postpartum, and doulas provide mothers with support at the hospital during labor, delivery, and with early breastfeeding. Additionally, mothers in the intervention group receive prenatal and long-term postpartum home visitation services through an evidence-based home visiting program, such as Parents as Teachers and Healthy Families Illinois. Mothers in the comparison group receive a less intensive case management service. Four existing doula home visiting programs located in economically distressed communities in Illinois were selected for participation in the study. At each site, young pregnant women are recruited for participation in the study, provide informed consent, and complete a baseline interview in their homes during mid-pregnancy. At completion of the baseline interview, mothers are randomly assigned to either the doula home visiting intervention group or the case management comparison group. At 37 weeks of pregnancy, and at 3 weeks-, 3 months-, 13 months-, and 30 months, and 4 years postpartum, mothers are interviewed in their homes on topics including pregnancy, parenting, health, mental health, feeding practices, employment/education, and relationships. Additionally, at all postpartum visits, mothers are videorecorded interacting with their infants. At the 13 month, 30 month, and 4 year followup sessions, children of the study participants are administered developmental and behavioral assessments. Based on prior studies of doula services and the goals of doula enhanced home visiting programs, a variety of outcomes are assessed at followup time points. These outcomes include prenatal medical care, prenatal bonding with infant, feelings of efficacy during labor, anesthesia use during labor, breastfeeding, positive parenting behaviors, parenting attitudes and stress, infant health, maternal health, maternal depressive symptoms, and child behavior and development.

Conditions

• Breast Feeding
• Parenting
• Child Development
• Depression, Postpartum

Interventions

Type	Name	Description
BEHAVIORAL	Doula Home Visiting	The intervention is a doula enhancement to evidence-based home visiting services. Doulas provide home visits during pregnancy and for the first six weeks postpartum, which focus on prenatal health, preparation for childbirth, bonding with the baby, and breastfeeding education. Family support workers provide longer term home visiting services. These home visits focus on sensitive and responsive parenting, early infant care, bonding with the baby, child health and development, and maternal mental health.
BEHAVIORAL	Case management	Mothers are offered two prenatal and two postpartum case management meetings to assess whether mothers' basic needs (housing, nutrition, health care, mental health) are being met and make appropriate referrals.

Timeline

• Start date: 2011-11-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2013-09-20
• Last updated: 2020-11-06